The Effect of Benralizumab and Mepolizumab on Use of Oral Glucocorticoids in Patients With Eosinophilic Granulomatosis With Polyangiitis.

More benralizumab-treated patients achieved complete withdrawal of oral glucocorticoids (OGCs).

更多的benralizumab治疗患者实现了口服糖皮质激素（OGCs）的完全停药。

The objectives of this post hoc analyses are to further elucidate the efficacy of benralizumab and mepolizumab in facilitating reductions in OGCs through investigating timings and sustainability of reducing OGCs as well as the cumulative use of OGCs.

本次事后分析的目标是进一步阐明benralizumab和mepolizumab在促进嗜酸性粒细胞减少方面的疗效，通过调查减少嗜酸性粒细胞的时间和持续性以及累积使用嗜酸性粒细胞的情况。

Methods

Adults with EGPA requiring ≥7.5 mg/day OGC with or without immunosuppressive therapy were randomized to benralizumab 30 mg (n = 70) or mepolizumab 300 mg (n = 70) subcutaneously every 4 weeks for 52 weeks.

需要≥7.5 mg/天嗜酸性粒细胞的成人EGPA患者，无论是否接受免疫抑制治疗，均被随机分配到每4周皮下注射benralizumab 30 mg（n = 70）或mepolizumab 300 mg（n = 70）治疗，持续52周。

Investigators tapered OGCs for patients with stable EGPA based on clinical judgment.

研究人员根据临床判断为稳定期嗜酸性粒细胞增多性肉芽肿（EGPA）患者逐渐减少OGCs的使用。

Reductions in OGC use (to ≤4 mg/day, by ≥50%, or complete withdrawal) were considered sustained if achieved by week 40 and maintained through week 52.

如果在第40周之前实现OGCs使用量减少（降至≤4 mg/天，减少≥50%，或完全停用）并维持至第52周，则认为这种减少是持续的。

Results

The 12-month cumulative dose of OGC was approximately 1,800 mg in both groups.

两组的OGC 12个月累积剂量大约为1800毫克。

At weeks 49 to 52, the median OGC dose was 1.16 (minimum-maximum 0.0-16.6) and 3.00 (minimum-maximum 0.0-25.7) mg/day for benralizumab and mepolizumab, respectively.

在第49至52周，benralizumab和mepolizumab的中位OGC剂量分别为1.16（最小值-最大值0.0-16.6）和3.00（最小值-最大值0.0-25.7）毫克/天。

Time to first or sustained OGC reduction to ≤4 mg/day or by ≥50% and accrued OGC-free duration were similar between groups.

首次或持续性OGC降低至≤4 mg/天或降低≥50%的时间以及累积的OGC无使用时间在各组之间相似。

More benralizumab- than mepolizumab-treated patients completely withdrew OGCs (33 of 70 vs 20 of 70; hazard ratio[HR] for the time to the first complete withdrawal 1.84 [95% confidence interval[CI] 1.06-3.27]; unstratified log-rank test P = 0.0291) and sustained complete withdrawal (17 of 70 vs 7 of 70; HR for time to reduction 2.97 [95% CI 1.26-7.77]; unstratified log-rank test P = 0.0268).

与接受mepolizumab治疗的患者相比，接受benralizumab治疗的患者完全停用OGC的人数更多（33/70 vs 20/70；首次完全停用时间的风险比[HR]为1.84 [95%置信区间[CI] 1.06-3.27]；未分层的Log-rank检验P = 0.0291）以及持续完全停用（17/70 vs 7/70；降低时间的风险比[HR]为2.97 [95% CI 1.26-7.77]；未分层的Log-rank检验P = 0.0268）。

In both groups, complete OGC withdrawal was similar across patient subgroups, including by antineutrophilic cytoplasmic antibody status and immunosuppressive use.

在两组中，完全撤除OGC的患者亚组相似，包括按抗中性粒细胞胞浆抗体状态和免疫抑制剂使用情况分类。

Conclusions

Targeting the interleukin-5 receptor with benralizumab or circulating interleukin-5 with mepolizumab are effective OGC-sparing strategies in patients with EGPA.

使用benralizumab靶向白细胞介素-5受体或使用mepolizumab靶向循环中的白细胞介素-5，是EGPA患者中有效的OGC节省策略。